Biotech Values

[AlpineBV_Miller]

My impression was that there was indeed some element of review and back/forth during the rolling submission process.

That's how rolling review was intended, but every company we've spoken with (n=dozen or so) has said they received nothing from the FDA except for an acknowledgement the file/truck o' paper was received. A couple of companies said they were notified the materials appeared to be complete, "subject to detailed review", but most didn't receive that.

It could be with our small sample size I'm getting the wrong impression, but I don't think so. The FDA has apparently indicated they don't want to waste scarce review time until the app is complete and, importantly, finalized. They don't want to review a submitted piece that might be changed later when the whole app is finalized. they also don't want to waste review time on an app that might never be complete.